Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

Act as the main line of communication between the project team, sponsor, and the siteBuild and maintain a good relationship with the site staff involved in the study conductPrepare, conduct, and report site selection, initiation, routine monitoring and close-out visitsEnsure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site levelEnsure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviationsPerform source data verification and follows up on data queries at site level; review and manage study risks on a site levelEnsure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sitesReview essential study documents and reconcile study Investigator Site File (ISF) / TMF at site levelEnsures quality (data integrity and compliance) at site levelConduct site audit preparation visits and resolve site audit findingsParticipate in study site audits and client onsite visits, as requiredEnsure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ WarehouseConduct project-specific training of site investigatorsSupport preparation of Investigator newslettersAssist Site Management Associates in maintaining study-specific and corporate tracking systems at site levelSupport preparation of draft regulatory and ethics committee submission packagesSupport collection of IP-RED packages at site/country levelFacilitate review and reconciliation of the study TMF on country and site levels 

Qualifications

 

College/University degree in Life Sciences or an equivalent combination of education, training & experience2+ years of independent on-site monitoring experienceExperience in all types of monitoring visits, in phases I-IIIExperience in Oncology and GI/GU highly preferredFull working proficiency in EnglishProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility to travel up to 75%Valid driver’s license (if applicable)

 

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.